Last updated: 10/02/2023 16:00:37
Post-marketing study of safety profile of Fluticasone Furoate/Vilanterol (FF/VI) in Chinese participants
GSK study ID
212302
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Post-Marketing observational study to evaluate safety profile of fluticasone Furoate/Vilanterol treatment in Chinese patients with asthma or chronic obstructive pulmonary disease
Trial description: This is multi-center, observational study, which will include participants who have been prescribed FF/VI 100/25 micrograms (mcg) administered once daily via the dry powder ELLIPTA™ inhaler. This post-marketing intensive monitoring study will collect and evaluate the safety profile of Chinese participants with asthma or chronic obstructive pulmonary disease (COPD) diagnosis. This study will include participants who have been prescribed FF/VI or who have been previously treated with FF/VI. At least 3000 participants from hospitals and pharmacy for intensive drug monitoring will be included. The maximum observation duration will be 24 weeks with 4 visits. An Electronic Data Capture (EDC) system will be used in this study. ELLIPTA is the registered trademark for GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of Chinese participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Week 24
Number of Chinese participants with known adverse drug reactions (ADRs)
Timeframe: Up to Week 24
Number of elderly Chinese participants with known ADRs
Timeframe: Up to Week 24
Number of renal impaired Chinese participants with known ADRs
Timeframe: Up to Week 24
Number of pregnant Chinese participants with known ADRs
Timeframe: Up to Week 24
Number of Chinese participants with unexpected ADRs
Timeframe: Up to Week 24
Number of Chinese participants with important identified events
Timeframe: Up to Week 24
Number of Chinese participants with important potential events
Timeframe: Up to Week 24
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-28-02
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2021 to February 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
NA - NA
Accepts healthy volunteers
No
- Participants should provide an appropriately signed and dated informed consent form (ICF)
- FF/VI treatment participants who have been prescribed FF/VI for a medically appropriate use will be included in this observational program. These include the participants who use FF/VI for the first time or who have been started FF/VI previously
- Participants who are not appropriate to be included by any reason judged by investigators.
- Participants with known drug or excipients allergy to FF/VI. Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on FF/VI that may impact participant eligibility is provided
Inclusion and exclusion criteria
Inclusion criteria:
- Participants should provide an appropriately signed and dated informed consent form (ICF)
- FF/VI treatment participants who have been prescribed FF/VI for a medically appropriate use will be included in this observational program. These include the participants who use FF/VI for the first time or who have been started FF/VI previously
- Participants must provide reliable contact method including home phone or cell phone for the follow up visits and have the ability to comply with study procedures.
Exclusion criteria:
- Participants who are not appropriate to be included by any reason judged by investigators.
- Participants with known drug or excipients allergy to FF/VI. Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on FF/VI that may impact participant eligibility is provided
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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